24 September 2024 - Santhera Pharmaceuticals announces that Swissmedic, the Swiss Agency for Therapeutic Products, has accepted for review the marketing authorisation application for Agamree (vamorolone) for the treatment of Duchenne muscular dystrophy.
Santhera asked Swissmedic to assess Agamree as part of Article 13 TPA (Therapeutics Product Act) procedure, allowing it to consider the results of foreign regulatory authorities’ assessments when reviewing a medicinal product for authorisation in Switzerland.